FDA 510(k)

HydraDose Vaginal Suppositories

Número K: K230518 · 2023-06-23

Data da decisão2023-06-23

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

HydraDose Vaginal Suppositories is the device name listed in this FDA 510(k) record. The listed applicant is MD Labs, LLC. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230518. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HydraDose Vaginal Suppositories?

HydraDose Vaginal Suppositories is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is MD Labs, LLC. The 510(k) number is K230518.

When did HydraDose Vaginal Suppositories receive FDA 510(k) clearance?

HydraDose Vaginal Suppositories received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230518.

Who is the listed applicant for HydraDose Vaginal Suppositories?

The FDA 510(k) record lists MD Labs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HydraDose Vaginal Suppositories?

The FDA product code for HydraDose Vaginal Suppositories is NUC.

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